Kornimate/medical-research-clean huggingface dataset:
absorption, metabolism, excretion and absolute bioavailability of edg-5506 in healthy volunteers

Conditions: Healthy Volunteer; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, Inborn

Summary: this is a phase 1 2-part, single-center, open-label study in healthy male volunteers. part a will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled edg-5506. part b will assess bioavailability of edg-5506 with a single oral dose of edg-5506 and a single intravenous dose of radiolabeled edg-5506.

this is a phase 1 2-part, single-center, open-label study. up to 15 (8 in part a and 7 in part b) healthy male subjects will be enrolled in the study. part a: potential subjects will be screened to assess eligibility within 28 days prior to dose administration. subjects will be admitted on day -1 and confined to the study site until at least day 30. on day 1, subjects will receive a single oral suspension. blood, urine and feces samples will be collected for determination of edg-5506 concentration, total radioactivity, and metabolite profiling and identification. between day 30 and day 36, subjects will be discharged. part b: potential subjects will be screened to assess their eligibility within 42 days prior to dose administration. subjects will be admitted on day -1 and confined to the study site until day 8. on day 1, subjects will receive a single oral dose of edg-5506 in the fasted state followed 2 hours later by a single dose of radiolabeled edg-5506. subjects will be discharged from the study site on day 8. blood samples will be collected.

Eligibility criteria:
inclusion criteria: 1. for both part a and part b, males, of any race, between 18 and 55 years of age, inclusive. 2. for both part a and part b, a body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight greater than or equal to 50 kg. 3. in good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram, vital signs measurements, and clinical laboratory evaluations at screening and check-in. exclusion criteria: 1. significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, immunological, or psychiatric disorder, as determined by the investigator (or designee). 2. participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to dosing. 3. participation in more than 3 radiolabeled drug studies in the last 12 months. 4. poor peripheral venous access. 5. subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.

Keywords: healthy volunteer
efficacy and tolerability study of zp-025 vaginal gel for the treatment of vaginal dryness

Conditions: Vaginal Dryness

Summary: evaluation of zp-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying zp-025 vaginal gel.

evaluation of zp-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days. this trial will be conducted in compliance with last version of declaration of helsinki, with gcp as applicable to investigations with imd, with the applicable regulatory requirements and with cro and sponsor's sops. this is a multi-centre, national, randomized, controlled vs. no-treatment, open label study the study will take place in 6 centers of menopause at public hospitals/universities. an ancillary study will be carried on for subjects randomized to zp-025 group with a follow-up visit at 4 weeks

Eligibility criteria:
inclusion criteria: * caucasian women \<70 years, in physiological postmenopausal status for at least 2 years; * women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching, dyspareunia, dryness); * signed informed consent; willing and able to comply with study procedures exclusion criteria: * childbearing potential women; * ascertained or presumptive hypersensitivity to the formulation ingredients; * therapy with systemic or vaginal oestrogens within 6 months from the inclusion; * current urinary or vaginal infection (cultural positive result to vaginal or urines microbiological swab in the 7 days preceding inclusion); * previous episodes of vaginal bleeding or spotting in the last 6 months; * vaginal prolapse and any other disease that could interfere with the study conduction and participation

Keywords: vaginal dryness vaginal gel colostrum vaginal atrophy
research study to look at side effects during regular injection with factor viii medicine named turoctocog alfa for a 8 weeks period

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this study will test the well-known medicine turoctocog alfa for any side effects. the purpose is to test turoctocog alfa for any side effects in the indian population. the participants will get turoctocog alfa. turoctocog alfa is already a well-known medicine in india, and can be prescribed by the study doctor. the participants will get an injection every second day or 3 times per week. this is decided by the study doctor. the study doctor will decide the amount and how often the participants must take the medicine. the study will last for about 16 weeks. the participants will have 5 visits with the study doctor. if the participants agree to participate in this study, the participants will receive the first injection at the second visit, thereafter the participants will be trained to do the injection by themself.


Eligibility criteria:
inclusion criteria: - informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - male, age above or equal to 12 years at the time of signing informed consent - patients with the diagnosis of congenital moderate or severe haemophilia a based on medical records. (fviii below or equal to 5%) - documented history of at least 150 eds (exposure days) to fviii containing products exclusion criteria: - confirmed inhibitors to fviii (above or equal to 0.6 bu) at screening as assessed by central laboratory - history of fviii inhibitors - known or suspected hypersensitivity to trial product(s) or related products - previous participation in this trial. participation is defined as signed informed consent - participation in any clinical trial of an approved or non-approved investigational medicinal product within 1 month before screening (visit 1) - any disorder, except for conditions associated with haemophilia a, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol - immunocompromised patients due to hiv infection (defined as viral load above or equal to 400.000 copies/ml and/or cd4+ lymphocyte count below or equal to 200/μl). hiv status and cd4+ lymphocyte count /viral load results may be obtained at screening or from available medical records; results must be not older than 6 months - known congenital or acquired coagulation disorders other than haemophilia a - mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation
effect of drinking fermented milk on immune response

Conditions: Influenza

Summary: this blinded randomized controlled trial aims to investigate the effect of drinking fermented milk containing lactobacillus paracasei (imulus) on immune response against influenza.

this study is conducted in healthy volunteer using product approved by thai fda. this blinded randomized controlled trial compare immune response against influenza h1n1, h3n2 and phu-b between study group and control group. the study group receives influenza vaccine and drinking fermented milk containing lactobacillus paracasei (imulus), while the control group receives influenza vaccine and placebo acidified milk. the trial lasts for 8 weeks and include four time points of data collection (0, 2, 6, 8 weeks). subjects, outcome assessor and investigators are blinded throughout the study.

Eligibility criteria:
inclusion criteria: * 18 45 years old * healthy and having normal vital signs * no history of uncontrolled systemic or autoimmune diseases * no signs or symptoms of respiratory infection * normal blood chemistry including complete blood count (cbc), liver and kidney function, lipid profile and fasting blood sugar * no history of influenza vaccine during the past 6 months * able to continuously take the intervention daily for 6 weeks * able to refrain from other probiotic products such as drinking fermented milk or yoghurt since the beginning till the end of data collection * accepted to receive influenza vaccine shot * able to refrain from receiving other vaccine during the trial * able to refrain from traveling to endemic area of influenza * able to communicate in thai and sign their written inform consent exclusion criteria: * under pregnancy or expected to be pregnant * lactose or milk protein intolerances * daily intake of probiotic product for one month prior to recruitment * chronic alcoholism * gi disturbance e.g. stomachache, frequent diarrhea or constipation * history of gi surgery * ongoing treatment with antibiotic or other immune affecting drugs e.g. glucocorticoids, chemotherapy, antibodies, ciclosporin, hormone and opioids

Keywords: influenza vaccine probiotic immune response
incorporation of vitamin k into uremic lipoproteins

Conditions: Vitamin K Deficiency

Summary: chronic kidney disease (ckd) patients have an increased cardiovascular risk with corresponding cardiovascular calcifications. ckd patients exhibit a functional vitamin k deficiency. calcification can be prevented by vitamin k intake. the aim of this study is to investigate the cause for the vitamin k deficiency beyond a diminished dietary vitamin k uptake.

this study is a monocentric, 1-armed interventional trial. participants will be recruited at the university hospital of the rwth aachen. we will analyse serially collected serum from 10 dialysis patients, after ingestion of a single vitamin k supplement, compared to healthy controls. lipoprotein fractions will be isolated and the corresponding vitamin k contents will be measured by chromatography. the vitamin k supplement contains 3 subforms of vitamin k: vitamin k1 (1000µg), menaquinone-4 (1000µg) and menaquinone-7 (200µg).

Eligibility criteria:
inclusion criteria * age ≥ 18 years * controls: adequate kidney function (gfr \> 60 ml/min/1,73m2) * patients: chronic haemodialysis * written consent to take part in the study exclusion criteria * intake of vitamin k antagonists * gastro-intestinal diseases interfering with vitamin k intake * profound anemia with an hb \< 10 g/dl * judicial or official commitment to an institution * pregnancy and lactation
a single-center,evaluation of the onset and duration of action of ac-170 0.24% compared to vehicle

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the onset and duration of action of ac-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (cac) model.


Eligibility criteria:
inclusion criteria: * positive bilateral conjunctival allergen challenge (cac)reaction exclusion criteria: * known contraindications or sensitivities to the study medication or its components * any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters * use of disallowed medication during the period indicated prior to the enrollment or during the study
triage-crt telemonitoring in patients with chf and indication of crt-d

Conditions: Congestive Heart Failure; Cardiac Resynchronization Therapy

Summary: this feasibility study will investigate the clinical benefit of the combined use of biotronik home monitoring (hm) and weight and blood pressure (bp) external telemonitoring (etm) in the follow-up treatment of patients implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (crt-d). the feasibility study is designed to plan and define endpoints for a larger randomized study. the study will assess the hm-parameter trends correlation with daily weight and blood pressure changes. the patient compliance rate of the two different telemonitoring systems (hm \& etm) will also be evaluated.

this single-arm, multi-center feasibility study will explore the clinical benefit of the combined use of biotronik home monitoring (hm) and weight and blood pressure (bp) external telemonitoring (etm) in the follow-up management of heart failure patients implanted with a cardiac resynchronization therapy implantable cardioverter defibrillator (crt-d). the biotronik home monitoring system will automatically and remotely collect device based information on a daily basis, and an external telemonitoring system will be used to determine the 'weight' and 'blood pressure' remotely at the patient's home on a daily basis. this study will evaluate retrospectively, if home monitoring parameters correlate with weight and blood pressure changes. the patient compliance rate of the two telemonitoring systems will also be assessed. target enrollment is up to 100 patients at 15 u.s. sites. patients will be enrolled within a period of 12 to 15 months. based on the follow-up period of 6 months per patient, the study duration is 18 to 21 months from the date of first patient enrollment. all patients will give written informed consent prior to enrollment and will be implanted with the legally marketed biotronik kronos lv-t, or an appropriate biotronik crt-d, as well as legally marketed pacing and defibrillation leads. in addition, all patients will be receiving a legally marketed external telemonitoring system to determine weight and blood pressure at home.

Eligibility criteria:
inclusion criteria: * able to provide written informed consent * implanted within the past 45 days or being considered for implant with a biotronik crt-d * age 18 years * able to follow and comply with the study related procedures * phone jack with landline connection at home to connect both the biotronik hm and the etm system * sufficient cognitive and reading skills to operate weight \& bp system ambulatory * weight ≤ 400 lbs exclusion criteria: * participation in another cardiovascular clinical study * life expectancy \<6 months

Keywords: congestive heart failure cardiac resynchronization therapy home monitoring telemonitoring remote monitoring
treatment for patients with osteoarthritis (oa)

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the clinical benefit (change in western ontario and mcmaster university osteoarthritis index \[womac\] pain score) of amg 108 (300 mg subcutaneously \[sc\] every 4 weeks) in subjects with oa.


Eligibility criteria:
inclusion criteria: * diagnosed with knee oa as determined by american college of rheumatology (acr) criteria * pain defined by a level of greater than or equal to 30 mm on a 100 mm visual analogue scale (vas) * if currently taking any over the counter nutritional supplements, must be on stable doses for greater than 2 months prior to screening * if utilizing physical therapy, biomechanical devices or orthotic support, must have been using treatment or device for greater than or equal to 2 months prior to screening * if currently or previously taking any non-prescribed supplement (e.g., glucosamine or chondroitin sulphate, shark cartilage, diacerein, soya extract, etc.) must be on stable doses for at least 2 months prior to screening * if currently taking nonsteroidal anti-inflammatory drugs (nsaids), must be on stable doses for at least 2 months prior to screening * able to discontinue nsaids at least 5 half-lives (approximately 3 days) prior to day 1 * radiographic evidence of tibio-femoral compartment knee oa within 12 months of screening * signed written informed consent exclusion criteria: * malignancy within the previous 5 years, except for basal cell or in situ cancer * significant hematologic disease - active infection or history of recurrent or chronic infections * known diagnosis of hiv, hepatitis b, or hepatitis c infection * uncontrolled diabetes or cardiovascular disease and hypertension * inflammatory arthropathy including secondary oa * isolated oa of the patellofemoral joint (bi or tri-compartmental involvement are not exclusions) * end-stage ("bone-on-bone") oa (kellgren lawrence score of 4) * oa of the hip ipsilateral to the index knee - total white cell count less than 2.0 x 10\^9/l and/or platelet count less than 100 x 10\^9/l observed within 1 month preceding screening * prior intra-articular (ia) injection of anakinra or experimental interleukin-1 (il-1) inhibitor therapy - concurrent treatment with sc anakinra * concurrent or recent (less than or equal to 1 month) use of experimental therapy * prior ia corticosteroid injection within 1 month of study * prior viscosupplement therapy within 3 months of study * contraindication(s) to ia injections * subjects who are pregnant or breast-feeding, or plan to become pregnant during the study * subject is not using adequate contraception * known allergy to e coli-derived products * unable to understand informed consent * concerns regarding subject's compliance with the protocol procedures * subject will not be available for follow-up assessment * active substance abuse

Keywords: intra-articular osteoarthritis oa anakinra amgen
comparison of different non-invasive methods to assess pulse wave analysis

Conditions: Blood Pressure; Arterial Stiffness; Arrythmia

Summary: the primary goal of the study is to compare different methods for pulse wave measurement and analysis which are cuffless and contactless. the novel measurement tools will be compared to cuff-based reference methods.


Eligibility criteria:
inclusion criteria: * older than 18 years * male or female sex * signed informed consent. exclusion criteria: * acute sickness which influences hemodynamic parameters * arm circumference is below or above the limits for the blood pressure of the reference method (i.e. below 20 or above 40 cm)
aortic dissection with 4-dimensional phase-contrast magnetic resonance imaging

Conditions: MRI

Summary: we prospectively collected information on consecutive patients who had been evaluated using 4d pc-mri for aortic pathology in a tertiary hospital between april 2018 and feb 2020. patients were eligible for inclusion in the study if they had a clinical indication for cta of aortic dissections.

the exclusion criteria were non-mri-compatible ferromagnetic devices and pregnancy. in addition, patients with poor compliance and with unstable status that prevented them from lying down for the mri protocol were excluded. initially, 26 patients evaluated. one patient was excluded due to fever at the scheduled time, and another was unable to lie down due to complicated spine disease. all patients underwent cta scan on a 64-slice multidetector scanner (somatom sensation 64; siemens healthcare, erlangen, germany) with the intravenous administration of contrast media, followed by 4d pc-mri to assess aortic pathology

Eligibility criteria:
patients were eligible for inclusion in the study if they had a clinical indication for cta of aortic dissections. the exclusion criteria were non-mri-compatible ferromagnetic devices and pregnancy. in addition, patients with poor compliance and with unstable status that prevented them from lying down for the mri protocol were excluded.

Keywords: cvs mri
cord blood for neonatal hypoxic-ischemic encephalopathy

Conditions: Neonatal Hypoxic Ischemic Encephalopathy

Summary: this is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous)umbilical cord blood in the first 14 days after birth if the baby is born with signs of brain injury.

the purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own)umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. for this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood cells for the carolinas cord blood bank or other public or private bank that uses accepted standards for collection and handling of cells, or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood cells if an adequate number of cells that meet carolinas cord blood bank quality standards are available in the first 14 postnatal days. study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months at duke's special infant care clinic. mri's will be obtained per clinical routine and results will be analyzed and described in study reports.

Eligibility criteria:
inclusion criteria: * mothers must have consented for cord blood collection at delivery * cord blood must be available for extraction of stem cells. * \>34 weeks gestation * cord or neonatal ph\ 16 milliequivalents per liter (meq/l) or history of acute perinatal event * either a 10 minute apgar \< 5 or continued need for ventilation. * all infants must have signs of encephalopathy within 6 hours of age. exclusion criteria: * inability to enroll by 14 days of age. * presence of known chromosomal anomaly. * presence of major congenital anomalies. * severe intrauterine growth restriction (weight \<1800g) * infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist. * parents refuse consent. * attending neonatologist refuses consent. * failure to collect the infant's cord blood and/or laboratory unable to process cord blood.

Keywords: hypoxic-ischemic encephalopathy autologous cord blood cells newborn infants